Assessing Acceptability and Feasibiity of STI Self-swab Testing, to be Offered at the Time of Telemed Medication Abortion Provision
NCT ID: NCT06951438
Last Updated: 2025-06-26
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
75 participants
Study Classification
INTERVENTIONAL
Study Start Date
2025-05-22
Study Completion Date
2026-06-30
Brief Summary
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The goal of this interventional study is to provide more access to STI testing for patients who seek abortion care through telemedicine, particularly for those whose access to STI testing is otherwise limited. The main questions it aims to answer are:
What is the acceptability, feasibility, and utilization of self-collected STI screening at the time of telemedicine medication abortion provision?
How does the uptake of such a service among patients receiving telemedicine abortion care compare to the population of patients who seek in-person medication abortion care?
What are the positivity rates for STIs in among patients receiving telemedicine medication abortion care compared to the positivity rates for a contemporaneous, in-clinic population?
What is the average time to between testing and treatment for patients who test positive for an STI using the self-collection service?
Researchers will compare the intervention group to a contemporaneous, in-clinic population on uptake of STI screening, as well as on positivity rates for the STIs tested.
Participants will be asked to perform self-swab collection for STI testing for gonorrhea, chlamydia, and trichomonas. They will be instructed to send their specimens to a lab using prepaid postage. Upon completion of sample collection and shipping, they will be asked to complete a survey assessing basic demographic information, as well as acceptability and feasibility of the intervention. Patients who test positive for an STI will be promptly provided/referred to treatment.
What is the acceptability, feasibility, and utilization of self-collected STI screening at the time of telemedicine medication abortion provision?
How does the uptake of such a service among patients receiving telemedicine abortion care compare to the population of patients who seek in-person medication abortion care?
What are the positivity rates for STIs in among patients receiving telemedicine medication abortion care compared to the positivity rates for a contemporaneous, in-clinic population?
What is the average time to between testing and treatment for patients who test positive for an STI using the self-collection service?
Researchers will compare the intervention group to a contemporaneous, in-clinic population on uptake of STI screening, as well as on positivity rates for the STIs tested.
Participants will be asked to perform self-swab collection for STI testing for gonorrhea, chlamydia, and trichomonas. They will be instructed to send their specimens to a lab using prepaid postage. Upon completion of sample collection and shipping, they will be asked to complete a survey assessing basic demographic information, as well as acceptability and feasibility of the intervention. Patients who test positive for an STI will be promptly provided/referred to treatment.
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Detailed Description
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Study Design:
This is an explorative cohort study that will assess the accessibility, feasibility, and utilization of a new intervention: at-home, self-collected STI testing at the time of medication abortion received through telemedicine services.
The study will take place within the Complex Family Planning clinic, the Options Center in Honolulu, Hawaii.
The intervention group will be recruited from the telemedicine medication abortion patients.
This group will be compared to the control group with data pulled from a chart review of a comparison cohort of patients seen for in-clinic medication abortion during a contemporaneous period.
Patients in the telehealth group may be physically based on any of the Hawaiian Islands but must have internet access for telehealth services. During the initial telemedicine consultation for medication abortion, the patient will be screened for eligibility using the eligibility criteria described as detailed below. If a patient is eligible for the study, they will be asked if they would like to be enrolled in the study in order to perform STI testing via self-collection. If they do not wish to participate in the study, resources for alternative ways to get STI testing will be provided to them.
If the patient expresses interest in the study, at the conclusion of their telemedicine visit for abortion care, they will redirected to a separate telemedicine visit with the research coordinator. The research coordinator will describe the study in further detail and obtain informed consent if the patient still wishes to proceed. Patients will sign consent forms via Adobe e-sign, a secure digital platform.
Once informed consent has been obtained, the research associate will do a short teaching session that reviews the following points with participants:
1. Contents of the specimen collection kit, which will include written instructions for specimen collection
2. How to collect the specimen (this may be done with illustrative models or drawings) and how to handle the specimen once it has been collected. This will include instructions on how to place the swab in the collection tube containing buffer solution, and how to send the swab to the lab. Patients will be instructed to collect their specimens for STI testing prior to taking their medications for medication abortion, in order to improve the ease of collection.
3. Verifying that patients are willing to receive a survey following specimen receipt via text message, and that they have a working mobile phone number.
4. Verifying that they accept receiving positive test results by phone.
5. Asking if, and how, patients would like to be notified of negative test results.
Patient information will be de-identified and connected to a unique Study ID. This study ID will label all specimens that patients send in the mail. All identifiable information, including signed consent forms, will be stored in a password protected and encrypted computer in the PI's research office on site.
The specimen collection kit will be included within the medication abortion kits, which are mailed to patients using a USPS bubble mailer. The patients will be able to locate their package by using a USPS tracking number once the kits have been mailed to them. Within the mailer, collection instructions and a prepaid envelope to send the specimens for processing will also be included. No PHI will be included in the specimen collection kit; all study materials sent to the laboratory for processing will be labeled only with the patient's study ID number.
Once the medication abortion kit and swab collection kit have been received, patients will perform self-swab collection before they initiate their medication abortion and send their specimen to the processing lab using the prepaid envelope provided for them. All specimens will be processed at the Emory Clinical Labs in Atlanta, GA. Once the lab has confirmed specimen receipt, the participant will receive a link via text message or email from the study team at QMC to a survey that assesses the acceptability and feasibility of the self-swab. This is a modified version of a validated survey that is used assess acceptability feasibility of telehealth-based interventions.18 The survey will also collect limited and non-identifiable demographic information. There will be a free-text portion at the end for patients to input any additional feedback regarding the intervention.
Once STI tests have been processed, the results will be emailed back to the research team using secure QMC email. All results sent through email will be deidentified, using only the patient's study ID number to identify the results. The lab staff will notify the PI if a submitted specimen is deemed inadequate for processing. If the swab is deemed inadequate, the research team will offer the patient the opportunity to swab again and provide them with a new test kit. Once the research team has received the results, they will be reported to the patient and scanned into the patient's electronic medical record.
If the lab staff does not receive a specimen from the patient prior to the patient's scheduled medication abortion follow-up appointment (typically scheduled 1-2 weeks after the initial consultation), the participant will be asked during the follow-up visit if they still desire or intend to send in a specimen, and reminded of the self-swab instructions if they express an intention to still complete the testing. If the patient does not attend her scheduled follow-up visit, one attempt will be made to contact her regarding specimen collection on the day of the scheduled appointment via phone call. If the study team is unsuccessful in contacting the patient at this time, no further attempts at contact will be made.
All patients who have a positive test result will be notified and provided options for treatment as soon as the research team is notified of the result. Patients may opt to receive negative test results via phone call (with option to approve leaving a detailed message on voicemail or not), Epic MyChart or text message, or opt out of receiving updates about negative test results.
Study population:
The study population will be patients living in Hawai'i who seek abortion care via telemedicine. The investigator team currently sees patients through telemedicine on six of the Hawaiian Islands (O'ahu, Maui, Hawai'i island, Kaua'i, Moloka'i, and Lāna'i). For many patients, specifically those located on Kaua'i, Lāna'i, and Moloka'i, medication abortion is the only option available for termination without having to fly to see an abortion provider. While Kaua'i has several in-person providers who provide medication abortion, on Lāna'i and Moloka'i, there are no providers on island who provide medication abortions in clinic, so telemedicine medication abortion is their only option.
Number of subjects
The investigator team will enroll a total of 75 subjects for this study. The guidance for determining sample sizes in pilot studies assessing feasibility recommends 70-100 subjects, which will allow analysis for correlation between variables without sacrificing significant confidence intervals. Additionally, in a very similar feasibility study assessing a telehealth STI intervention for same-sex male couples,15 the sample comprised of 50 couples, with samples collected from 100 study subjects.
For the contemporaneous, in-clinic population that will serve as the control group, all charts for patients who receive medication abortion in the same time frame that recruitment for the study took place will be reviewed.
This is an explorative cohort study that will assess the accessibility, feasibility, and utilization of a new intervention: at-home, self-collected STI testing at the time of medication abortion received through telemedicine services.
The study will take place within the Complex Family Planning clinic, the Options Center in Honolulu, Hawaii.
The intervention group will be recruited from the telemedicine medication abortion patients.
This group will be compared to the control group with data pulled from a chart review of a comparison cohort of patients seen for in-clinic medication abortion during a contemporaneous period.
Patients in the telehealth group may be physically based on any of the Hawaiian Islands but must have internet access for telehealth services. During the initial telemedicine consultation for medication abortion, the patient will be screened for eligibility using the eligibility criteria described as detailed below. If a patient is eligible for the study, they will be asked if they would like to be enrolled in the study in order to perform STI testing via self-collection. If they do not wish to participate in the study, resources for alternative ways to get STI testing will be provided to them.
If the patient expresses interest in the study, at the conclusion of their telemedicine visit for abortion care, they will redirected to a separate telemedicine visit with the research coordinator. The research coordinator will describe the study in further detail and obtain informed consent if the patient still wishes to proceed. Patients will sign consent forms via Adobe e-sign, a secure digital platform.
Once informed consent has been obtained, the research associate will do a short teaching session that reviews the following points with participants:
1. Contents of the specimen collection kit, which will include written instructions for specimen collection
2. How to collect the specimen (this may be done with illustrative models or drawings) and how to handle the specimen once it has been collected. This will include instructions on how to place the swab in the collection tube containing buffer solution, and how to send the swab to the lab. Patients will be instructed to collect their specimens for STI testing prior to taking their medications for medication abortion, in order to improve the ease of collection.
3. Verifying that patients are willing to receive a survey following specimen receipt via text message, and that they have a working mobile phone number.
4. Verifying that they accept receiving positive test results by phone.
5. Asking if, and how, patients would like to be notified of negative test results.
Patient information will be de-identified and connected to a unique Study ID. This study ID will label all specimens that patients send in the mail. All identifiable information, including signed consent forms, will be stored in a password protected and encrypted computer in the PI's research office on site.
The specimen collection kit will be included within the medication abortion kits, which are mailed to patients using a USPS bubble mailer. The patients will be able to locate their package by using a USPS tracking number once the kits have been mailed to them. Within the mailer, collection instructions and a prepaid envelope to send the specimens for processing will also be included. No PHI will be included in the specimen collection kit; all study materials sent to the laboratory for processing will be labeled only with the patient's study ID number.
Once the medication abortion kit and swab collection kit have been received, patients will perform self-swab collection before they initiate their medication abortion and send their specimen to the processing lab using the prepaid envelope provided for them. All specimens will be processed at the Emory Clinical Labs in Atlanta, GA. Once the lab has confirmed specimen receipt, the participant will receive a link via text message or email from the study team at QMC to a survey that assesses the acceptability and feasibility of the self-swab. This is a modified version of a validated survey that is used assess acceptability feasibility of telehealth-based interventions.18 The survey will also collect limited and non-identifiable demographic information. There will be a free-text portion at the end for patients to input any additional feedback regarding the intervention.
Once STI tests have been processed, the results will be emailed back to the research team using secure QMC email. All results sent through email will be deidentified, using only the patient's study ID number to identify the results. The lab staff will notify the PI if a submitted specimen is deemed inadequate for processing. If the swab is deemed inadequate, the research team will offer the patient the opportunity to swab again and provide them with a new test kit. Once the research team has received the results, they will be reported to the patient and scanned into the patient's electronic medical record.
If the lab staff does not receive a specimen from the patient prior to the patient's scheduled medication abortion follow-up appointment (typically scheduled 1-2 weeks after the initial consultation), the participant will be asked during the follow-up visit if they still desire or intend to send in a specimen, and reminded of the self-swab instructions if they express an intention to still complete the testing. If the patient does not attend her scheduled follow-up visit, one attempt will be made to contact her regarding specimen collection on the day of the scheduled appointment via phone call. If the study team is unsuccessful in contacting the patient at this time, no further attempts at contact will be made.
All patients who have a positive test result will be notified and provided options for treatment as soon as the research team is notified of the result. Patients may opt to receive negative test results via phone call (with option to approve leaving a detailed message on voicemail or not), Epic MyChart or text message, or opt out of receiving updates about negative test results.
Study population:
The study population will be patients living in Hawai'i who seek abortion care via telemedicine. The investigator team currently sees patients through telemedicine on six of the Hawaiian Islands (O'ahu, Maui, Hawai'i island, Kaua'i, Moloka'i, and Lāna'i). For many patients, specifically those located on Kaua'i, Lāna'i, and Moloka'i, medication abortion is the only option available for termination without having to fly to see an abortion provider. While Kaua'i has several in-person providers who provide medication abortion, on Lāna'i and Moloka'i, there are no providers on island who provide medication abortions in clinic, so telemedicine medication abortion is their only option.
Number of subjects
The investigator team will enroll a total of 75 subjects for this study. The guidance for determining sample sizes in pilot studies assessing feasibility recommends 70-100 subjects, which will allow analysis for correlation between variables without sacrificing significant confidence intervals. Additionally, in a very similar feasibility study assessing a telehealth STI intervention for same-sex male couples,15 the sample comprised of 50 couples, with samples collected from 100 study subjects.
For the contemporaneous, in-clinic population that will serve as the control group, all charts for patients who receive medication abortion in the same time frame that recruitment for the study took place will be reviewed.
Conditions
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Sexually Transmitted Disease (STD)
Gonorrhea
Chlamydia
Trichomonas Infection
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
HEALTH_SERVICES_RESEARCH
Blinding Strategy
NONE
Study Groups
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Self-swab Arm
These patients will be recruited to the study actively. Upon signing an informed consent, they will be instructed to collect an at-home, self-swab test for STI testing. The kit for collection will be provided for them, as well as the shipping materials for the specimen.
Group Type
EXPERIMENTAL
Self-swab collection PCR test for chlamydia, gonorrhea, trichomonas
Intervention Type
DIAGNOSTIC_TEST
Self-swab collection PCR test for chlamydia, gonorrhea, trichomonas
in-clinic STI testing arm
This population will not be actively recruited. Demographic data will be collected for comparison to the intervention arm via retrospective chart review of a contemporaneous, in-clinic population seeking abortion care.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Self-swab collection PCR test for chlamydia, gonorrhea, trichomonas
Self-swab collection PCR test for chlamydia, gonorrhea, trichomonas
Intervention Type
DIAGNOSTIC_TEST
Eligibility Criteria
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Inclusion Criteria
1. Patients of the Queen Medical Center Options Center clinic seeking telemedicine medication abortion.
2. Patients for whom, according to the CDC guidelines for STI Testing11, STI testing is indicated, or patients who desire STI screening
3. Age 14 and over
4. Can speak and read English
5. Displays capacity for informed consent
2. Patients for whom, according to the CDC guidelines for STI Testing11, STI testing is indicated, or patients who desire STI screening
3. Age 14 and over
4. Can speak and read English
5. Displays capacity for informed consent
Exclusion Criteria
1. Home address that is not located in the state of Hawai'i
2. Incarcerated
3. Unwilling to perform vaginal swab collection
2. Incarcerated
3. Unwilling to perform vaginal swab collection
Minimum Eligible Age
14 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
Yes
Sponsors
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University of Hawaii Foundation
UNKNOWN
Sponsor Role
collaborator
Queen's Medical Center
OTHER
Sponsor Role
lead
Responsible Party
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Olivia Manayan, MD MPH
Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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Queens Medical Center, 1004 Clinic POB1
Honolulu, Hawaii, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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Olivia H Manayan, MD, MPH
Role: primary
808-348-7859
References
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Gaydos CA, Cartwright CP, Colaninno P, Welsch J, Holden J, Ho SY, Webb EM, Anderson C, Bertuzis R, Zhang L, Miller T, Leckie G, Abravaya K, Robinson J. Performance of the Abbott RealTime CT/NG for detection of Chlamydia trachomatis and Neisseria gonorrhoeae. J Clin Microbiol. 2010 Sep;48(9):3236-43. doi: 10.1128/JCM.01019-10. Epub 2010 Jul 28.
Reference Type
BACKGROUND
US Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for HIV, STD and TB Prevention (NCHSTP), Division of STD/HIV Prevention, Sexually Transmitted Disease Morbidity for selected STDs by age, race/ethnicity and gender 1996-2014, CDC WONDER Online Database. Accessed 2025 Jan 7. http://wonder.cdc.gov/std-race-age.html.
Reference Type
BACKGROUND
The Guttmacher Institute. State laws and policies: An overview of consent to reproductive health services by young people. Published 2023 Aug 30. Accessed 2024 Dec 26. https://www.guttmacher.org/state-policy/explore/overview-minors-consent-law
Reference Type
BACKGROUND
Committee Opinion No. 665: Guidelines for Adolescent Health Research. Obstet Gynecol. 2016 Jun;127(6):e183-e186. doi: 10.1097/AOG.0000000000001486.
Reference Type
BACKGROUND
Haydon HM, Major T, Kelly JT, Catapan SC, Caffery LJ, Smith AC, Gallegos-Rejas V, Thomas EE, Banbury A, Snoswell CL. Development and validation of the Digital Health Acceptability Questionnaire. J Telemed Telecare. 2023 Dec;29(10_suppl):8S-15S. doi: 10.1177/1357633X231202279.
Reference Type
BACKGROUND
Teresi JA, Yu X, Stewart AL, Hays RD. Guidelines for Designing and Evaluating Feasibility Pilot Studies. Med Care. 2022 Jan 1;60(1):95-103. doi: 10.1097/MLR.0000000000001664.
Reference Type
BACKGROUND
Spielberg F, Levy V, Lensing S, Chattopadhyay I, Venkatasubramanian L, Acevedo N, Wolff P, Callabresi D, Philip S, Lopez TP, Padian N, Blake DR, Gaydos CA. Fully integrated e-services for prevention, diagnosis, and treatment of sexually transmitted infections: results of a 4-county study in California. Am J Public Health. 2014 Dec;104(12):2313-20. doi: 10.2105/AJPH.2014.302302. Epub 2014 Oct 16.
Reference Type
BACKGROUND
Sullivan SP, Sullivan PS, Stephenson R. Acceptability and Feasibility of a Telehealth Intervention for STI Testing Among Male Couples. AIDS Behav. 2021 Dec;25(12):4029-4043. doi: 10.1007/s10461-021-03173-4. Epub 2021 Jan 28.
Reference Type
BACKGROUND
Lunny C, Taylor D, Hoang L, Wong T, Gilbert M, Lester R, Krajden M, Ogilvie G. Self-Collected versus Clinician-Collected Sampling for Chlamydia and Gonorrhea Screening: A Systemic Review and Meta-Analysis. PLoS One. 2015 Jul 13;10(7):e0132776. doi: 10.1371/journal.pone.0132776. eCollection 2015.
Reference Type
BACKGROUND
Center for Disease Control. Screening recommendations and considerations referenced in treatment guidelines and original sources. Published 2024 Mar 22. Accessed 2024 Oct 1. https://www.cdc.gov/std/treatment-guidelines/screening-recommendations.htm
Reference Type
BACKGROUND
Norris A, Upadhyay U, O'Donnell J, et al. #WeCount report: April 2022 to June 2024. Society of Family Planning. Published 2024 Oct 22. doi:10.46621/728122kflzwf
Reference Type
BACKGROUND
Kerestes C, Murayama S, Tyson J, Natavio M, Seamon E, Raidoo S, Lacar L, Bowen E, Soon R, Platais I, Kaneshiro B, Stowers P. Provision of medication abortion in Hawai'i during COVID-19: Practical experience with multiple care delivery models. Contraception. 2021 Jul;104(1):49-53. doi: 10.1016/j.contraception.2021.03.025. Epub 2021 Mar 28.
Reference Type
BACKGROUND
Barrow RY, Ahmed F, Bolan GA, Workowski KA. Recommendations for Providing Quality Sexually Transmitted Diseases Clinical Services, 2020. MMWR Recomm Rep. 2020 Jan 3;68(5):1-20. doi: 10.15585/mmwr.rr6805a1.
Reference Type
BACKGROUND
McNicholas C, Madden T, Secura G, Peipert JF. The contraceptive CHOICE project round up: what we did and what we learned. Clin Obstet Gynecol. 2014 Dec;57(4):635-43. doi: 10.1097/GRF.0000000000000070.
Reference Type
BACKGROUND
Frost JJ, Gold RB, Bucek A. Specialized family planning clinics in the United States: why women choose them and their role in meeting women's health care needs. Womens Health Issues. 2012 Nov-Dec;22(6):e519-25. doi: 10.1016/j.whi.2012.09.002.
Reference Type
BACKGROUND
Frost JJ, Mueller J, Pleasure ZH. Trends and differentials in receipt of sexual and reproductive health services in the United States: services received and sources of care, 2006-2019. Guttmacher Institute. https://www.guttmacher.org/report/sexual-reproductive-health-services-in-us-sources-care-2006-2019. Published 2021 Jun.
Reference Type
BACKGROUND
Srinivas M, Wong NS, Wallace R, Emch M, Tang W, Yang EJ, Tucker JD. Sexually Transmitted Infection Rates and Closure of Family Planning Clinics Because of Abortion Restrictions in Iowa. JAMA Netw Open. 2022 Oct 3;5(10):e2239063. doi: 10.1001/jamanetworkopen.2022.39063.
Reference Type
BACKGROUND
Baden K, Dreweke J, Gibson C. Clear and growing evidence that Dobbs is harming reproductive health and freedom. Published 2024 Aug 22. Accessed 2024 Oct 1. https://www.guttmacher.org/2024/05/clear-and-growing-evidence-dobbs-harming-reproductive-health-and-freedom.
Reference Type
BACKGROUND
Abortion in the United States. Published 2024 Jun 25. Accessed 2024 Oct 1. https://www.guttmacher.org/fact-sheet/induced-abortion-united-states.
Reference Type
BACKGROUND
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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RA-2025-009
Identifier Type: -
Identifier Source: org_study_id
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